Efficacy of Extra Virgin Olive Oil (EVOO) Supplementation on Serum COX-2, Malondialdehyde, TNF-alpha, and Hand-Foot Syndrome Incidence in Patients With Capecitabine
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Serum COX-2 Concentration
研究概览
简要总结
The study was aimed to evaluate the efficacy of extra virgin olive oil (EVOO) supplementation compared to placebo to prevent HFS by observing changes in serum COX 2, malondialdehyde (MDA), and TNF α levels in breast cancer and colorectal cancer patients undergoing capecitabine chemotherapy. Current study was designed as a single-center prospective randomized clinical trial. The patients were Stage III or Stage IV colorectal and breast cancer patients receiving capecitabine-based chemotherapy who enrolled in the trial voluntarily. All patients were divided randomly into three groups treated with EVOO, olive oil, or placebo. The incidence of hand foot syndrome was documented. The serum COX 2, malondialdehyde (MDA), and TNF α levels before and after chemotherapy was documented.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients pathologically and clinically diagnosed with III or IV stadium of breast cancer or colorectal cancer.
- •fully recovered after curative resection within 8 weeks
- •receive adjuvant capecitabine based chemotherapy
排除标准
- •did not meet the eligibility criteria for chemotherapy
- •had previous allergy with capecitabine or olive oil
结局指标
主要结局
Serum COX-2 Concentration
时间窗: 3 cycle of chemotherapy (63 days)
Serum COX-2 Concentration
Hand Foot Syndrome
时间窗: 3 cycle of chemotherapy (63 days)
Patients was documented for hand and foot syndrome using WHO criteria. There were 4 grade assessed by patient symptoms of tingling or burning or painful sensation, palmar or plantar erythema or desquamation, and/or ulceration.
Serum Tumor Necrosis Factor Alpha Concentration
时间窗: 3 cycle of chemotherapy (63 days)
Serum Tumor Necrosis Factor Alpha Concentration
Serum malondialdehyde concentration
时间窗: 3 cycle of chemotherapy (63 days)
Serum malondialdehyde ceoncentration
次要结局
未报告次要终点
研究者
Yenny Andayani
Head of Hematology and Clinical Oncology Division, Department of Internal Medicine, Universitas Sriwijaya/Mohammad Hoesin General Hospital
Universitas Sriwijaya